Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Easymed Instruments Co., Ltd. — Predicate Candidate Screening
3 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K241899 | Pelvic Floor Stimulator (Intrelief PFE) | Easymed Instruments Co., Ltd. | 2024-11-27 | 152 | 0 |
| K211263 | Intrelief | Easymed Instruments Co., Ltd. | 2021-12-30 | 248 | 0 |
| K140168 | EASYSTIM TN28_OTC | Easymed Instruments Co., Ltd. | 2014-08-28 | 217 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda